The initiation of the 150-day evaluation for an MHRA Marketing application is triggered by:
2. Being informed MAA passed validation.
Here's why:
Option 1 (receipt of MAA) doesn't guarantee a valid application. The MHRA needs to first assess the application for completeness and compliance. Option 3 (MAA validation confirmed) might be redundant. "Passed validation" is the usual term used after a successful assessment. [color=red]The MHRA specifically outlines in their guidance that the 150-day clock starts ticking after a valid application is submitted [2]. A valid application is one that has passed the initial validation stage.[/color]